The 2024 Pinnacle 21 User Group Meeting is your chance to explore, with its architects and your peers, our newly expanded suite of capabilities, from metadata management to accelerated SDTM generation. Learn best practices from case studies, ask questions about our roadmap, and gather with your fellow data leaders.
Location
Convene CityView, 30 S 17th St, Philadelphia, PA 19103
Agenda
9am to 9:15am Welcome
9:15 to 10am Product Overview, Vision, and Roadmap – CTO Max Kanevsky and product leaders present on the end-to-end platform, covering study build through TFLs and submission, including integration with Certara Cloud.
10 to 10:30am Regulatory Update – FDA and PMDA experts Michael Beers and Seiko Yamazaki present on implications of the latest changes from Health Authorities, including best practices for optimizing study data for global multi-agency submissions, with tips for emerging agencies NMPA, EMA, MFDS.
10:30 to 10:45am Break
10:45 to 11:15am Metadata Repository Exploration – Product leaders Erin Erginer and Darren Bill provide their first-hand experience of how integrated form design and study build truncates timelines toward SDTM via options for full automation for metadata-driven SAS programming.
11:15am to 12pm Customer Spotlight – Using ryze for study automation, from start to finish
12 to 12:30pm Feedback session breakout intro – Pick your booth. Visit our live support desk for troubleshooting bugs and/or our product design usability testing to improve the user experience of our next release.
12:30 to 1pm Networking Lunch – Enjoy a meal while engaging with industry peers and representatives from Certara.
1 to 1:45pm Integrations: P21E, Formedix ryze, Certara Cloud – Head of Certara Cloud, Phillip Johnston, presents how Certara’s increasingly unified platform simplifies user and asset management, and allows cross-study and cross-product insights to emerge.
1:45 to 2:15pm Expert Discussion Panel – Try to stump our product SME and engineering experts with your most challenging edge cases, standardization ambiguities, techniques for process change.
2:15 to 3pm Customer Spotlight – An Approach to SDTM and ADaM Programming.
3 to 3:15pm Break
3:15 to 4pm Stack Rank Your Pain Points: Add to our pre-event survey of client requests, discuss in small groups with our experts which problems’ solutions would have the highest ROI for your organization and the industry.
4 to 4:45pm From Forms to SDTM: Acceleration Approaches
4:45 to 5pm Closing Remarks and Survey